PIPERACILLIN AND TAZOBACTAM VERSUS CLINDAMYCIN AND GENTAMICIN IN THE TREATMENT OF HOSPITALIZED WOMEN WITH PELVIC INFECTION

Objective: To compare the efficacy and safety of a combination of pipe racillin and tazobactam with that of clindamycin and gentamicin in the treatment of hospitalized women with infections of the upper genital tract. Methods: This was a randomized open-label trial in hospitalized women with infections of the upper genital tract. Patients were recru ited at 12 hospitals in the United States and two hospitals in Canada and were randomly assigned to one of two regimens in a 2:1 ratio. One group received piperacillin, 3 g every 6 hours, and tazobactam, 375 mg every 6 hours; the other group received clindamycin, 900 mg every 8 h ours, and gentamicin, 2.5-5.0 mg/kg/day in three divided doses. Therap y with the assigned regimen was to be administered for a minimum of 3 days. Cultures for aerobic and anaerobic bacteria were obtained from t he site of infection before initiation of therapy. Cultures for Chlamy dia trachomatis were also obtained from patients with endometritis or pelvic inflammatory disease. Subjects were evaluated for clinical and bacteriologic response at 24-72 hours and 2-4 weeks after completing t herapy. Results: Two hundred ninety-nine patients were enrolled; 196 w ere in the piperacillin-tazobactam group and 103 were in the clindamyc in-gentamicin group. The most common diagnoses were endometritis (146) and pelvic inflammatory disease (115). The most common microorganisms recovered included: Peptostreptococcus sp (99), Prevotella sp (87), b lack pigmented Bacteroides (29), B fragilis (11), enterococci (64), gr oup B streptococcus (26), Escherichia coli (31), Neisseria gonorrhoeae (49), and C trachomatis (19). A favorable clinical response occurred in 84.7% (166 of 196) of piperacillin-tazobactam patients and 87.3% (9 0 of 103) of clindamycin-gentamicin patients. Among those evaluable fo r bacteriologic response, 78% (67 of 86) and 82% (23 of 28), respectiv ely, had a favorable response. Diarrhea occurred significantly more fr equently in the piperacillin-tazobactam group (9.7 versus 2.9%; P =.04 ), but the majority of episodes were mild to moderate. None of the adv erse experiences in either treatment group were considered life-threat ening and drug-related. Conclusion: The combination of piperacillin an d tazobactam is an effective and well-tolerated antibiotic regimen for the treatment of infections of the upper genital tract in women.